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Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images

Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04763785
Acronym
DKDA
Enrollment
4800
Registered
2021-02-21
Start date
2021-05-11
Completion date
2023-12-01
Last updated
2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Corneal Ectasia, Eye Diseases, Keratoconus

Keywords

Keratoconus, Eye Diseases, Cataract, Corneal Imaging, Corneal Topography, Corneal Tomography, Corneal Ectasia

Brief summary

Monocentric clinical study to develop an imaging analysis algorithm for the Eyestar 900 to identify keratoconus corneas and improve biometry for intraocular lens calculations

Detailed description

Keratoconus is a progressive corneal ectatic disorder, characterised by thinning, protrusion and irregularity. Corneal imaging is crucial in keratoconus detection and progression analysis. Detection of keratoconus in early stages is important and has therapeutic consequence, whether to plan a surgical intervention or calculating an intraocular lens, before cataract surgery, as standard lens calculation techniques may lead to wrong results in patients with a keratoconus. The Eyestar 900 is a swept-source OCT biometer and has the potential to be used for early keratoconus identification and progression analysis.

Interventions

DEVICECorneal tomography with Eyestar 900

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

DEVICECorneal tomography with Pentacam

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

DEVICEBiometry with IOL-Master

Non-invasive biometry for presurgical intraocular lens calculation

OTHERretrospective analysis, no intervention

retrospective analysis of 4500 existing, fully anonymised picture data

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Patients with all stages of keratoconus 2. Patients with healthy corneas

Exclusion criteria

1. Keratoconus patients with hydrops, status following hydrops 2. Patients with degenerative corneal diseases 3. Patients after corneal surgery

Design outcomes

Primary

MeasureTime frameDescription
Keratoconus identification2.5 yearsClassification accuracy of the keratoconus identification algorithm for the Eyestar device in comparison to the gold standard (Belin-Ambrosio Enhanced Extasia Deviation Index) BAD\_D in Pentacam images.

Secondary

MeasureTime frameDescription
Feasibility in clinical practice2.5 yearsEvaluation of the feasibility (percentage of valid measurements without errors and/or problems in image aquisition) of cornea measurements in keratoconus and healthy eyes.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026